Duns Number:529174252
Device Description: 1-50 mL & 1-200ml Syringes 2 1-50 mL & 1-200ml Syringes 2-Fill Straws 1-72" Y Coiled Tubing with Dual Check Valves
Catalog Number
HS-NCD520
Brand Name
Sinton Medical Products
Version/Model Number
100125-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
d402856d-72c5-41cb-8df6-28059a0c1a4a
Public Version Date
November 26, 2020
Public Version Number
1
DI Record Publish Date
November 18, 2020
Package DI Number
26938327909066
Quantity per Package
20
Contains DI Package
06938327909062
Package Discontinue Date
November 18, 2020
Package Status
Not in Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |